Cystic FibrosisPhase 2NCT00221546
Influence of DHA-rich Supplement on DHA-status and Health Evolution of Patients With Cystic Fibrosis
A Phase 2 study testing Giving DHA-rich supplement in people with Cystic Fibrosis, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Investigation of the influence of giving DHA-rich supplement versus placebo on DHA-status and health evolution of patients with cystic fibrosis Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Giving DHA-rich supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2007to Sep 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Delta F 508 homozygote
- Stable clinical situation
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Investigation of the influence of giving DHA-rich supplement versus placebo on DHA-status and health evolution of patients with cystic fibrosis
Read the detailed description
Investigation of the influence of giving DHA-rich supplement versus placebo on DHA-status and health evolution of patients with cystic fibrosis
- Conditions
- Cystic Fibrosis
- Being tested
- Giving DHA-rich supplement
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Giving DHA-rich supplementDrug
Giving DHA-rich supplement to patients.
| Study group | Role | What they receive |
|---|---|---|
| DHA-rich supplement | Active comparator | Not described Receives: Drug: Giving DHA-rich supplement |
| Placebo | Placebo comparator | Not described Receives: Drug: Giving DHA-rich supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical evolution: weight, height, pulmonary function and infection frequency before the study start and during the 2 years of the study
Measured: before the study start and during the 2 years of the study
Secondary outcomes (2)
Evolution of the fatty acid profile
Measured: during the 2 years of the study
Oxidative stress status
Measured: during the 2 years of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startSep 2007
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Belgian Society against Cystic Fibrosis
- Responsible party
- Sponsor
- Investigators
- Armand Christophe, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00221546
- Sponsor's protocol ID
- 2001/220
- Status last verified
- Sep 2011
- First submitted
- 12 Sep 2005
- Last updated
- 28 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of DHA-rich Supplement on DHA-status and Health Evolution of Patients With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT00221546
- Acronym / sponsor ID
- 2001/220
- Conditions
- Cystic Fibrosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Belgian Society against Cystic Fibrosis
- Study start
- Sep 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigation of the influence of giving DHA-rich supplement versus placebo on DHA-status and health evolution of patients with cystic fibrosis
Detailed description
Investigation of the influence of giving DHA-rich supplement versus placebo on DHA-status and health evolution of patients with cystic fibrosis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DHA-rich supplement | Active comparator | Drug: Giving DHA-rich supplement |
| Placebo | Placebo comparator | Drug: Giving DHA-rich supplement |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Delta F 508 homozygote
- Stable clinical situation
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Giving DHA-rich supplementGiving DHA-rich supplement to patients. | Drug | DHA-rich supplement, Placebo |
Primary outcome
Clinical evolution: weight, height, pulmonary function and infection frequency before the study start and during the 2 years of the study
Time frame: before the study start and during the 2 years of the study
2 secondary outcomes
Evolution of the fatty acid profile
Time frame: during the 2 years of the study
Oxidative stress status
Time frame: during the 2 years of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2011.
- Website University Hospital GhentLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Armand Christophe, MD, PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Giving DHA-rich supplement in people with Cystic Fibrosis, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical evolution: weight, height, pulmonary function and infection frequency before the study start and during the 2 years of the study (time frame: before the study start and during the 2 years of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2011.